WizDx™ COVID-19 CrystalMix PCR Kit (CE-IVD)
INTENDED USE
WizDx™ COVID-19 CrystalMix PCR Kit is intended to be used to achievequalitative detection of 2019-Novel Coronavirus (COVID-19) viral RNAextracted from nasopharyngeal swabs, oropharyngeal swabs, and sputumfrom patients.
PRINCIPLES OF THE TEST
WizDx™ COVID-19 CrystalMix PCR Kit combines all the reagents necessaryfor successful one-step real-time RT-PCR in a convenient individually aliquotand lyophilized in 8-strip qPCR tube.WizDx™ COVID-19 CrystalMix PCR Kit uses dual-labeled hydrolysis probesthat target two distinct regions in RdRP (RNA-dependent RNA polymerase)gene and E (Envelop) gene of SARS-CoV-2 genome. Detection probe forRdRP gene is labeled with FAM and the probe for E gene is labeled with HEXreporter dye.
KFDA License No. : 20-301CE-IVD marked